Section 8.11: No Violation of Law

Applies to: Agreement V3.0

Section 8.11 (added in Version 2.0 as Section 8.10 at NIH's request, and renumbered in Version 3.0) states that nothing in the Agreement requires a Participating Institution to act in violation of applicable law, regulation, or other federal or state requirements. SMART IRB is not aware of any current conflict; the provision exists in case one arises.

What it covers. Conflicts between a term of the Agreement and a law, regulation, or other governmental requirement — including federal or state agency funding terms and policies. It does not cover conflicts with an institution's private contracts; institutions manage those themselves.

What an institution must do. If complying with a provision would cause a violation, the institution notifies the other affected Participating Institutions and works with them to find a mutually agreeable alternative — a different way to satisfy the provision, or a decision by the others not to insist on performance for that study. (Under §8.9, choosing not to insist on performance in one case is not a waiver of the Agreement.) If no alternative can be found, the research is withdrawn from ceded review with respect to the affected institutions, without an IRB approval or disapproval (§2.5.2.3).

See also - Working together when there is a dispute or breach - Ending a reliance arrangement for a study